Date: 2015-11-10
Type of information: Licensing agreement
Compound: naproxcinod
Company: Nicox (France) Fera Pharmaceuticals (USA - NY)
Therapeutic area: Rheumatic diseases - Inflammatory diseases
Type agreement: licensing
Action mechanism: non-steroidal anti-inflammatory drug. Naproxcinod is a CINOD (Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti-inflammatory candidate.
Disease: osteoarthritis
Details: * On November 10, 2015, Nicox and Fera Pharmaceuticals, a privately-held specialty pharmaceutical company, announced that they have entered into an exclusive license agreement for the development and commercialization of Nicox’s naproxcinod, a CINOD (Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti-inflammatory candidate, in the United States. Fera’s initial focus will be the signs and symptoms of osteoarthritis. Fera plans to seek advice from the FDA regarding the additional clinical work required before submitting a New Drug Application (NDA) for naproxcinod. Nicox already completed a broad clinical program for naproxcinod in osteoarthritis, including three phase 3 studies with over 2,700 patients.
The agreement covers all indications excluding ophthalmology-related conditions and Duchenne Muscular Dystrophy, and Nicox will retain all rights for naproxcinod outside of the U.S. Fera is eligible to
receive an undisclosed royalty should naproxcinod be approved and commercialized in any indication in any
ex-U.S. territory using data generated by Fera. A joint steering committee will be put in place with
representation from both companies to ensure that development of naproxcinod proceeds in accordance
with the agreement.
The U.S. intellectual property relating to this transaction is comprised of a patent for the naproxcinod S enantiomer which is protected until 2021 as well as a formulation patent.
Financial terms: Under the terms of the agreement, Nicox will be eligible to receive up to $35 million in sales-based milestones, plus 7 percent royalties based on net sales of naproxcinod in the U.S. Fera will be responsible for, and will fully finance, all clinical development, manufacturing and commercialization activities.
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